A Study to Evaluate the Safety and Efficacy of Pumitamig in Combination With Chemotherapy Versus Nivolumab in Combination With Chemotherapy in Participants With Previously Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (ROSETTA Gastric-204)

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Bristol-Myers Squibb
Study ID
NCT07221149
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

  • Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pumitamig — DRUG
    Specified dose on specified days
  • Folfox — DRUG
    Specified dose on specified days
  • Capox — DRUG
    Specified dose on specified days
  • Nivolumab — DRUG
    Specified dose on specified days

Study Details

The purpose of this study is to evaluate the safety and efficacy of Pumitamig in combination with chemotherapy versus Nivolumab in combination with chemotherapy in participants with previously untreated advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma

Key Dates

Start date
Mar 13, 2026
Status verified
Jun 2026
Primary completion
Nov 8, 2030
Completion
Sep 11, 2032

Study Design

Enrollment
690 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A1
  • Experimental: Arm A2
  • Experimental: Arm C
  • Experimental: Arm D

Primary Outcome Measure

Objective Response (OR) (confirmed complete response (CR) or partial response (PR)) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per investigator assessment [ Time Frame: Up to 2 years after the last participant is randomized ]

Central Contacts

  • BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
    855-907-3286
    [email protected]
  • First line of the email MUST contain NCT # and Site #.

Locations (34)

FacilityCityStateZIPSite coordinators
Local Institution - 0284PhoenixArizona85054
Site 0284
Local Institution - 0437Los AngelesCalifornia90033
Site 0437
University of California, Irvine (UCI) Health - UC Irvine Medical CenterOrangeCalifornia92868
Farshid Dayyani, Site 0277
714-456-5153
Local Institution - 0428San FranciscoCalifornia94158
Site 0428
Florida Cancer Specialists - SouthFort MyersFlorida33901
Fadi Kayali, Site 0429
239-274-9930
Local Institution - 0433JacksonvilleFlorida32224
Site 0433
Florida Cancer Specialists - NorthSt. PetersburgFlorida33701
Muhammad Imam, Site 0430
000-000-0000
Local Institution - 0246TampaFlorida33612
Site 0246
Local Institution - 0377AtlantaGeorgia30308
Site 0377
Local Institution - 0379ChicagoIllinois60637
Site 0379
Local Institution - 0268Iowa CityIowa52242
Site 0268
Local Institution - 0259RochesterMinnesota55905
Site 0259
Missouri Cancer AssociatesColumbiaMissouri65201
Caleb Smith, Site 0426
573-874-7800
Local Institution - 0286OmahaNebraska68198
Site 0286
Northwell Health/ RJ Zuckerberg Cancer CenterLake SuccessNew York11042
Nicholas Hornstein, Site 0386
323-533-7275
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Yelena Janjigian, Site 0242
646-888-4186
Local Institution - 0274RochesterNew York14642
Site 0274
Local Institution - 0245Chapel HillNorth Carolina27599
Site 0245
Local Institution - 0222ClevelandOhio44195
Site 0222
Local Institution - 0443ClevelandOhio44106
Site 0443
Oncology Associates Of Oregon, PcEugeneOregon97401
Marc Uemura, Site 0432
541-214-8284
Northwest Cancer Specialists, P.C.PortlandOregon97213-2982
Spencer Shao, Site 0419
503-528-5005
Local Institution - 0407PittsburghPennsylvania15213
Site 0407
Local Institution - 0255NashvilleTennessee37203
Site 0255
SCRI Oncology PartnersNashvilleTennessee37203
Meredith Pelster, Site 0417
615-986-4366
Texas Oncology - Amarillo Cancer CenterAmarilloTexas79124
Anton Melnyk, Site 0423
325-692-0188
Texas Oncology-Austin CentralAustinTexas78731
Vivian Cline, Site 0416
512-427-9400
Texas OncologyBeaumontTexas77702
Pavel Levin, Site 0424
Texas Oncology - Northeast TexasDenisonTexas75020
Amir Faridi, Site 0415
000-000-0000
Texas Oncology - DFWGrapevineTexas76051
Ravi Patel, Site 0421
Local Institution - 0233HoustonTexas77030
Site 0233
Texas Oncology - San AntonioSan AntonioTexas78240
John R. Ogden, Site 0427
Oncology and Hematology Associates of Southwest Virginia, Inc. - SalemSalemVirginia24153
Mark Kochenderfer, Site 0413
540-982-0237
Local Institution - 0271MadisonWisconsin53792
Site 0271

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By research site
Local Institution - 0284· Phoenix, AZLocal Institution - 0437· Los Angeles, CAUniversity of California, Irvine (UCI) Health - UC Irvine Medical Center· Orange, CALocal Institution - 0428· San Francisco, CAFlorida Cancer Specialists - South· Fort Myers, FLLocal Institution - 0433· Jacksonville, FL